Medical Device Registration Verification 2026: Analysis of 15 National Public Data Files Finds Row Counts Mislead Compliance and Market-Sizing Decisions, Driven by Divergent File Structures and Completeness Gaps: Pure Global

Divergent file "grain," incomplete risk-class and manufacturer-country fields, and public databases commonly mistaken for live registers are reshaping how manufacturers, distributors and investors verify medical-device registrations across global markets, according to a new analysis from Pure Global.

JERSEY CITY, N.J., Sept. 3, 2026 /PRNewswire/ -- Pure Global, a global medical-device regulatory consulting and market-access firm, today published Medical Device Registration Verification 2026: What 15 National Public Data Files Actually Contain, a comparative analysis of public registration files from 15 jurisdictions. The study's central finding: a public register is not a market map. Because what one row represents — the file's "grain" — differs from country to country, raw row counts routinely mislead teams that use these files to verify whether a device is registered or to estimate market presence.

Read the full analysis, including grain tables and column-completeness maps, at https://www.pureglobal.com/blog-posts/medical-device-registration-verification-2026.

Analysis Overview
The analysis examines normalized extracts from ten national authorities — Singapore HSA, Malaysia MDA, Indonesia KEMKES, UAE EDE, Israel AMAR, Bangladesh DGDA, Brazil ANVISA, Mexico COFEPRIS, Argentina ANMAT and Ecuador ARCSA — alongside comparative data from the U.S. FDA, EUDAMED and additional jurisdictions including Australia, Canada, Korea, Japan and Colombia. Data snapshots range from May through August 2026. Before any two files can be compared, the study argues, the grain of each must be named: a product listing, a procedure bulletin, an issuance list or a catalog item are different regulatory objects that happen to look alike in a spreadsheet.

"Row counts are records, not installed base — and a missing name match is not an illegal product," said Ran Chen, Chief Technology Officer at Pure Global. "Before anyone treats a public file as evidence, they have to name what one row actually is: a certificate, a catalog item, a decision record or a document crawl. That single step prevents most of the verification errors we see."

Key Findings: How File Grain Distorts Row Counts
Identical-looking metrics describe very different regulatory objects across the files analyzed:

• Ecuador (ARCSA): the catastro holds 254,292 rows but only 23,198 distinct registration numbers — about 11 catalog items per certificate.
• Argentina (ANMAT Helena): the bulletin contains 47,325 rows against 28,594 distinct registration numbers.
• Canada (MDALL): 153,142 device identifiers are listed across just 35,387 licenses — roughly 4.3 identifier rows per license.
• Singapore (HSA SMDR): runs nearly one row per registration (20,860 rows, 20,858 registration numbers), yet excludes Class A devices entirely; those sit in a separate database.

Completeness Gaps Across National Authorities
Even where grain is understood, column completeness varies sharply across the ten national files audited:

• Risk classification is populated in only five of the ten files — Singapore, Indonesia, Brazil, Mexico and Bangladesh — and absent in the other five.
• Manufacturer country is complete in Indonesia, Brazil and Israel, and missing or sparse elsewhere.
• The UAE EDE file contains zero registration numbers across all 4,740 rows.

Two Databases Commonly Mistaken for Live Registers

• FDA 510(k): the database holds 175,559 records, but these are clearance decisions accumulated over decades — not a current product listing.
• EUDAMED: of 2.9 million device models, the authorized-representative name field is filled on only 48.5%.

The study recommends keeping both in a reference folder for verification work rather than treating either as a register of what is on the market today.

Regulatory Structure Issues Behind Common Misreadings

• Mexico (COFEPRIS): published lists represent annual publications, not comprehensive all-history registrations.
• Colombia (INVIMA): the file mixes medical devices with other sanitary product groups.
• Australia (ARTG): medicines must be filtered out before device counts are meaningful.
• Korea (MFDS): withdrawn records inflate raw counts.
• Japan (PMDA): the public file is a crawl of IFU documents, not a registration register.

A Nine-Step Verification Sequence
For teams verifying registrations against public files, the analysis sets out a nine-step playbook:

• Name the unit being counted before comparing any two files.
• Identify each file's grain — product listing, procedure bulletin, issuance list or catalog item.
• Lock identity fields such as registration numbers before matching.
• Treat name searches as clues only, never as conclusions.
• Read status and expiry at the correct grain.
• Open sister databases where classes or product groups are split across files.
• Confirm each file's official cut date.
• Decide what in-country roles remain to be appointed.
• Keep FDA 510(k) and EUDAMED in a reference folder, separate from registers.

What It Costs When the Row Is the Wrong Object
Misreading a public file carries real costs: due-diligence hours spent chasing records that were never the right object, a partner's validly registered device treated as unregistered because a name search missed, market sizes overstated from inflated row counts, and in-country roles that still need to be appointed going unnoticed until they hold up a launch. The analysis separates these avoidable costs from the fees that legitimately apply in every market — government charges and the cost of maintaining local representation.

In-Country Representation at Published Flat Rates
For companies that identify gaps in local representation, Pure Global publishes flat annual rates — from $1,000 for U.S. Agent appointment and $2,000 for most markets, including EU Authorized Representative, Australian Sponsor and Singapore Registrant equivalents, to $3,000 for higher-risk registrations, with a typical four-market bundle at $9,000 per year. The complete schedule is available at https://www.pureglobal.com/services/pricing.

Related Deep Research from Pure Global
The registration-verification analysis joins Pure Global's Deep Research series, which includes recent reports on coronary stents, surgical robots, in-vitro diagnostics, orthopedic implants and the ISO 10993-1:2025 transition, all available on the Pure Global blog at https://www.pureglobal.com.

Explore Registration Data with Pure Global's Free AI Tools
Pure Global maintains free AI-powered regulatory databases and tools, including searchable registration data across major markets, at https://pureglobal.ai.

About Pure Global
Pure Global is a medical device regulatory consulting firm with 15+ offices across five continents, supporting medical device and IVD companies with global market access, medical device registration strategy, and ongoing regulatory compliance. Pure Global operates across key markets including the United States, European Union, Brazil, Mexico, Colombia, and ASEAN, providing guidance from local regulatory specialists to streamline market entry and maintain compliance worldwide.

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SOURCE Pure Global